My HPRA: Register

Find Forms and Applications

Title File Type File Size Published Date  
Application for Licence for Category 1 Scheduled Substances (Precursor Chemicals) .docx 84 KB 07/02/2022 View more information
Application for certificates of free sale for in vitro diagnostic medical devices compliant with IVDR .docx 106 KB 04/02/2022 View more information
IMP expedited assessment of variations to Annex 3 and or 4 application form .docx 98 KB 31/01/2022 View more information
IMP immediate notification of variations to Annex 3 and or 4 application form .docx 95 KB 31/01/2022 View more information
Application for a Wholesale Distribution Authorisation .docx 116 KB 31/01/2022 View more information
Application to vary a wholesale distribution authorisation .docx 120 KB 31/01/2022 View more information
Application for Registration of Manufacturer, Importer or Distributor of Active Substances .docx 112 KB 28/01/2022 View more information
Application for variation to a manufacturer's authorisation .docx 128 KB 28/01/2022 View more information
Application for Transfer of an Authorisation for Manufacturing Medicinal Products for Human Use .docx 107 KB 28/01/2022 View more information
Application for Transfer of an Authorisation for Manufacturing Investigational Medicinal Products .docx 71 KB 28/01/2022 View more information
Application to Withdraw an Authorisation Licence Approval or Registration .docx 111 KB 28/01/2022 View more information
Application for Transfer of a Licence for Manufacturing Medicinal Products for Veterinary Use .docx 107 KB 28/01/2022 View more information
Application for a renewal of a veterinary authorisation .docx 101 KB 28/01/2022 View more information
Tissue Establishment Annual Report .docx 105 KB 01/12/2021 View more information
Tissue Establishment Annual Report for Reproductive Tissues and Cells .docx 117 KB 01/12/2021 View more information
Self-reporting of non-compliances under scientific animal protection legislation .docx 103 KB 25/08/2021 View more information
Notification of a clinical investigation under Article 82 MDR .docx 121 KB 16/06/2021 View more information
Application for certificates of free sale for medical devices, system and procedure packs compliant with MDR .docx 106 KB 27/05/2021 View more information
Application for certificates for free sale (MDD medical devices system and procedure packs legacy devices) .docx 109 KB 27/05/2021 View more information
Notification of a clinical investigation of a CE marked medical device (Article 74 MDR) .docx 118 KB 20/05/2021 View more information
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